Yayoi FemTech Inc.

Yayoi FemTech Inc. specializes in reusable menstrual cups and discs made from non-latex materials. These devices are designed for internal collection of menstrual fluid and are intended to be washed and reused across multiple menstrual cycles. The company focuses exclusively on this category of products.

Yayoi FemTech Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s device classification system. The U.S. regulatory framework applies to manufacturers headquartered or operating within the country, ensuring compliance with local standards.

Yayoi FemTech Inc.’s devices are classified as FDA Class II under U.S. regulations. This classification indicates a moderate level of risk, requiring specific controls like performance standards or post-market surveillance to ensure safety and effectiveness. Class II classification means the devices undergo additional scrutiny compared to Class I but are not as strictly regulated as Class III (high-risk) devices.

Yes, Yayoi FemTech Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This means each product has a unique identifier linked to its regulatory status, manufacturing details, and compliance information. For users, this listing ensures traceability and transparency, allowing them to verify the device’s authorized status and recall history if needed.

Yayoi FemTech Inc.’s menstrual cups and discs are designed for reusable use after cleaning between cycles, distinguishing them from single-use alternatives. This reuse aspect influences their regulatory classification because reusable medical devices—even those with low risk—must meet durability, sterilization (or cleaning), and long-term safety standards. The FDA’s Class II designation accounts for these factors, ensuring the devices remain safe and effective over multiple uses.